`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`
`BLUEBIRD BIO, INC.
`Petitioner
`
`v.
`
`SLOAN KETTERING INSTITUTE FOR CANCER RESEARCH,
`Patent Owner
`
`_________________
`
`Patent No. 8,058,061
`_________________
`
`PETITIONER’S CURRENT LIST OF EXHIBITS
`
`
`
`IPR2023-00074
`Patent No. 8,058,061
`
`Ex. No.
`
`Description
`
`LIST OF EXHIBITS
`
`Ex.1001 U.S. Patent No. 8,058,061 to Sadelain et al. (“the ’061
`patent”)
`
`Ex.1002 Declaration of Jörg Bungert, Ph.D.
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`Ex.1003
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`Curriculum Vitae of Jörg Bungert, Ph.D.
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`Ex.1004
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`Ex.1005
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`Ex.1006
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`May, “Therapeutic Hemoglobin Synthesis in
`Beta-Thalassemic Mice Expressing Lentivirus-Encoded Beta-
`Globin,” Cornell University (2001) (“the May Thesis”)
`
`May, et al., “Therapeutic Haemoglobin Synthesis in β-
`thalassaemic Mice Expressing Lentivirus-Encoded Human β-
`globin,” Nature, 406:82-86 (2000) (“the May Article”)
`
`May, et al., “Lentiviral-Mediated Transfer of the Human β-
`Globin Gene and Large Locus Control Region Elements
`Permit Sustained Production of Therapeutic Levels of β-
`Globin in Long-Term Bone Marrow Chimeras,” Mol.
`Therapy, 1(5):S248-249 (2000) (“the May Abstract”)
`
`Ex.1007
`
`Perutz, et al., “Hemoglobin Structure and Respiratory
`Transport,” Sci. Am., 239(6): 92-125 (1978)
`
`Ex.1008
`
`Thein & Rochette, “Disorders of Hemoglobin Structure and
`Synthesis,” in Principles of Mol. Med. 179 (Jameson, ed.,
`1998)
`
`Ex.1009
`
`Bank, et. al, “Disorders of Human Hemoglobin,” Science,
`207:486-93 (1980)
`
`Ex.1010
`
`He & Russell, “Expression, Purification, and Characterization
`of Human Hemoglobins Gower-I (ζ2ε2), Gower-2 (α2ε2), and
`Portland-2 (ζ2β2) Assembled in Complex Transgenic-
`Knockout Mice, Blood, 97(4):1099-1105 (2001)
`
`Previously
`Submitted
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`1
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`IPR2023-00074
`Patent No. 8,058,061
`
`Ex.1011
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`Bunn, “Pathogenesis and Treatment of Sickle Cell Disease,”
`N. Engl. J. Med., 337(11):762-69 (1997)
`
`Ex.1012
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`Hardison, et al., “Locus Control Regions of Mammalian β-
`globin Gene Clusters: Combining Phylogenetic Analyses and
`Experimental Results to Gain Function Insights, Gene,
`205:73-94 (1997)
`
`Ex.1013
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`Civin, et al., “Sustained, Retransplantable, Multilineage
`Engraftment of Highly Purified Adult Human Bone Marrow
`Stem Cells In Vivo,” Blood, 88(11):4102-09 (1996)
`Ex.1014 High, “Gene Therapy in Haematology and Oncology,”
`Lancet, 356:S8 (2000)
`
`Ex.1015
`
`Ex.1016
`
`Ellis, et al., “Evaluation of β-globin Gene Therapy Constructs
`in Single Copy Transgenic Mice,” Nucleic Acids Res.,
`25(6):1296-1302 (1997)
`
`Li, et al., “Nucleotide Sequence of 16-Kilobase Pairs of DNA
`5’ to the Human ε-Globin Gene,” J. Biol. Chem.,
`260(28):14901-10 (1985)
`
`Ex.1017
`
`Mishima, et al., “The DNA Deletion in an Indian δβ-
`thalassaemia Begins One Kilobase From the Aγ Globin Gene
`and Ends in an L1 Repetitive Sequence,” Br. J. Haemotol.,
`73:375-79 (1989)
`Ex.1018 Vosberg, “Molecular Cloning of DNA: An Introduction Into
`Techniques and Problems,” Hum. Genet. 40(1):1-72 (1977)
`
`Ex.1019
`
`Roberts, “Restriction Enzymes and Their Isoschizomers,”
`Nucleic Acids Res., 15(Suppl.):r189-r217 (1987)
`
`Ex.1020
`
`Ex.1021
`
`Zufferey, et al., “Multiply Attenuated Lentiviral Vector
`Achieves Efficient Gene Delivery in Vivo,” Nature Biotech.,
`15:871-75 (1997)
`
`Miyoshi, et al., “Transduction of Human CD34+ Cells that
`Mediate Long-Term Engraftment of NOD/SCID Mice by HIV
`Vectors,” Science, 283:682-86 (1999)
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`2
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`IPR2023-00074
`Patent No. 8,058,061
`
`Ex.1022
`
`Ex.1023
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`Ex.1024
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`Ex.1025
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`Ex.1026
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`Ex.1027
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`Ex.1028
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`Ex.1029
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`Ex.1030
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`Ex.1031
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`Ex.1032
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`Ex.1033
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`Sadelain, et. al., “Generation of a High-titer Retroviral Vector
`Capable of Expressing High Levels of the Human β-Globin
`Gene,” Proc. Natl. Acad. Sci. USA, 92:6728-32 (1995)
`
`Bouhassira, et al., “Transcriptional Behavior of LCR
`Enhancer Elements Integrated at the Same Chromosomal
`Locus by Recombinase-Mediated Cassette Exchange,” Blood
`90(9):3332-44 (1997)
`
`Fraser, et al., “Each Hypersensitive Site of the Human
`β-Globin Locus Control Regions Confers a Different
`Developmental Pattern of Expression on the Globin Genes,”
`Genes Dev., 7:106-113 (1993)
`
`Engel, “Developmental Regulation of Human β-Globin Gene
`Transcription: A Switch of Loyalties?,” Trend. Genet.,
`9(9):304-09 (1993)
`
`Roberts & Macelis, “REBASE – Restriction Enzymes and
`Methylases,” Nucleic Acids Res., 26(1):338-350 (1998)
`
`Roberts & Macelis, “REBASE – Restriction Enzymes and
`Methylases,” Nucleic Acids Res., 27(1):312-13 (1999)
`
`Roberts & Macelis, “REBASE – Restriction Enzymes and
`Methylases,” Nucleic Acids Res., 28(1):306-07 (2000)
`
`Roberts & Macelis, “REBASE – Restriction Enzymes and
`Methylases,” Nucleic Acids Res., 29(1):268-69 (2001)
`
`Sequence Manipulation Suite (last visited October 11, 2022)
`(Website)
`
`Restriction Mapper, April 20, 2001 Wayback Machine
`Capture (last visited October 11, 2022) (Website)
`
`Prosecution History of the ’179 patent
`(U.S. Patent Application No. 10/188,221)
`
`Prosecution History of the ’061 patent
`(U.S. Patent Application No. 12/433,412)
`
`3
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`X
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`X
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`X
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`IPR2023-00074
`Patent No. 8,058,061
`
`Ex.1034 U.S. Provisional Application 60/301,861 to Sadelain
`
`Ex.1035 U.S. Provisional Application 60/302,852 to Sadelain
`
`Ex.1036 Declaration by Ingrid Hsieh-Yee, Ph.D.
`
`Ex.1037
`
`SciMago, Nature (last visited October 11, 2022) (Website)
`
`Ex.1038
`
`Ex.1039
`
`SciMago, Molecular Therapy (last visited October 11, 2022)
`(Website)
`
`SciMago, Journal of Biological Chemistry (last visited
`October 11, 2022) (Website)
`
`Ex.1040
`Steele, “Editorial,” Mol. Therapy, 1(5):S1 (2000)
`Ex.1041 Glorioso, “Highlights from the Third Annual ASGT
`Meeting,” Mol. Therapy, 2(2):96-100 (2000)
`
`Ex.1042
`
`“Author Index,” Mol. Therapy, 1(5):S345-61 (2000)
`
`Ex.1043
`
`Ex.1044
`
`Ex.1045
`
`Ex.1046
`
`San Rocco Therapeutics, LLC v. bluebird bio, Inc. et al., C.A.
`No. 21-1478-RGA, D.I. 75 (D. Del. July 26, 2022)
`
`San Rocco Therapeutics, LLC v. bluebird bio, Inc. et al., C.A.
`No. 21-1478-RGA, D.I. 76 (D. Del. July 26, 2022)
`
`San Rocco Therapeutics, LLC v. bluebird bio, Inc. et al., C.A.
`No. 21-1478-RGA, D.I. 78 (D. Del. July 28, 2022)
`
`Vidal, “Interim Procedures for Discretionary Denials in AIA
`Post-Grant Proceedings with Parallel District Court Litigation
`(June 21, 2022)
`
`Ex.1047
`
`Himanen, et. al., “A Recombinant Sickle Hemoglobin Triple
`Mutant With Independent Inhibitory Effects on
`Polymerization.” J. Biol. Chem. 271(41):25152-56 (1996)
`(“Himanen”)
`Ex.1048 Declaration of K. Ho ISO Motion for Admission Pro Hac
`Vice
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`4
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`X
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`X
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`X
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`IPR2023-00074
`Patent No. 8,058,061
`
`Ex.1049 Declaration of M. Yusem IOS Motion for Admission Pro Hac
`Vice
`
`X
`
`Ex.1050
`
`Ex.1051
`
`Ex.1052
`
`Corrected Images for Paragraph 113 and 114 of Dr. Bungert’s
`October 18, 2022 Declaration (Ex. 1002)
`
`Transcript of Deposition of Dr. Stefano Rivella on September
`25, 2023
`
`Transcript of Deposition of Dr. James Riley on September 28,
`2023
`
`Ex.1053
`
`Transcript of Deposition of Dr. Chad May on October 6, 2023
`
`Ex.1054
`
`Nature Guide to Authors, January 2000 Wayback Machine
`Capture (last visited October 23, 2023) (Website)
`
`Ex.1055
`
`Ex.1056
`
`Ex.1057
`
`Ex.1058
`
`Nature Portfolio, “Reporting Standards and Availability of
`Data, Materials, Code and Protocols,” (last visited October 23,
`2023) (Website)
`
`Boulad, et.al., “Lentiviral Globin Gene Therapy With
`Reduced-Intensity Conditioning in Adults with β-
`Thalassemia: A Phase 1 Trial.” Nature Medicine, 68:63-82
`(2022)
`
`Sadelain, et. al., “Progress Towards the Genetic Treatment of
`the β-Thalassemias.” Ann. N.Y. Acad. Sci., 1054:78-91
`(2005)
`
`Sadelain, “Recent Advances in Globin Gene Transfer for the
`Treatment of Beta-Thalassemia and Sickle Cell Anemia.”
`Curr. Opin. Hemtol., 13:142-48 (2006)
`
`Ex.1059
`
`American Society of Gene Therapy Website, May 11, 2000
`Wayback Machine Capture (last visited October 23, 2023)
`(Website)
`Ex.1060 Molecular Therapy Journal Abstracts, June 7, 2000 Wayback
`Machine Capture (last visited October 23, 2023) (Website)
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`IPR2023-00074
`Patent No. 8,058,061
`
`Ex.1061
`
`Ex.1062
`
`American Society of Gene Therapy General Meeting
`Information, June 15, 2000 Wayback Machine Capture (last
`visited October 23, 2023) (Website)
`
`American Society of Gene Therapy, Abstracts of Scientific
`Presentations: The Third Annual Meeting of the American
`Society of Gene Therapy, August 18, 2000 Wayback Machine
`Capture (last visited October 23, 2023) (Website)
`
`Ex.1063
`
`[intentionally omitted]
`
`Ex.1064
`
`Excerpts of SRT’s Initial Infringement Claim Charts from San
`Rocco Therapeutics, LLC v. Bluebird Bio, Inc. and Third
`Rock Ventures, C.A. No. 21:1478-RGA (D. Del.)
`
`Ex.1065
`
`[intentionally omitted]
`
`Ex.1066
`
`Transcript of Deposition of Dr. Michel Sadelain on October
`20, 2023
`
`Ex.1067
`
`Transcript excerpts of YouTube video of Patrick Girondi
`TrialSite interview (uploaded to YouTube on May 18, 2023),
`available at:
`https://www.youtube.com/watch?v=EsJ29bT7t8M
`Ex.1068 Email Correspondence re. Dr. Luzzatto Deposition
`Availability, September 20, 2023
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`Dated: October 31, 2023
`
`Respectfully submitted,
`
`By: /Naveen Modi/
` Naveen Modi (Reg. No. 46,224)
` Counsel for Petitioner
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`I hereby certify that I caused to be served on the counsel identified below a
`
`true and correct copy of the foregoing Petitioner’s Current List of Exhibits by
`
`electronic means on October 31, 2023:
`
`FOR THE PATENT OWNER:
`Michael W. Glynn, Ph.D. (Reg. No. 76,729) (mglynn@foxrothschild.com)
`Fox Rothschild LLP
`101 Park Avenue, 17th Floor
`New York, NY 10178
`Telephone: (212) 878-7900
`Facsimile: (212) 692-0940
`
`Joe Chen, Ph.D. (Reg. No. 70,066) (joechen@foxrothschild.com)
`Fox Rothschild LLP
`997 Lenox Drive
`Lawrenceville, NJ 08648
`Telephone: (609) 844-3024
`Facsimile: (609) 896-1469
`
`Wanda French-Brown (wfrench-brown@foxrothschild.com)
`Howard S. Suh (hsuh@foxrothschild.com)
`James H. McConnell (jmcconnell@foxrothschild.com)
`Fox Rothschild LLP
`101 Park Avenue, 17th Floor
`New York, NY 10178
`Telephone: (212) 878-7900
`Facsimile: (212) 692-0940
`
`
`Dated: October 31, 2023
`
`
`
`Respectfully submitted,
`
`By: /Naveen Modi/
` Naveen Modi (Reg. No. 46,224)
` Counsel for Petitioner
`
`
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